Powder Free Nitrile Patient Examination Gloves, Black color

K152271 · Suqian Xingye Glove Co,Ltd · LZA · Feb 9, 2016 · General Hospital

Device Facts

• Record ID: K152271
• Device Name: Powder Free Nitrile Patient Examination Gloves, Black color
• Applicant: Suqian Xingye Glove Co,Ltd
• Product Code: LZA · General Hospital
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Patient Examination Gloves, Black Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Nitrile examination gloves; non-sterile; disposable. Function as physical barrier against body fluids and bloodborne pathogens. Material properties allow for hand conformation and movement during medical procedures. Used in clinical settings by healthcare providers. Protects both patient and examiner from contamination.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (powder residual), and ISO 10993-10 (biocompatibility: skin irritation and dermal sensitization).

Technological Characteristics

Nitrile rubber material; non-sterile; powder-free. Dimensions and physical properties conform to ASTM D6319-10. Freedom from pinholes per ASTM D5151-06 (AQL 2.5). Powder residual <2mg/glove per ASTM D6124-06. Biocompatibility per ISO 10993-10.

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Black Nitrile Powder Free Exam Glove (K133307)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2016

Suqian Xingye Glove Co, Ltd % Chu Xiaoan Official Correspondent Beijing Easylink Co. Ltd Rm. F302 Bldg. 41 Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100121 CHINA

Re: K152271

Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 03, 2016 Received: January 11, 2016

Dear Chu Xiaoan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Chu Xiaoan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith, M.S. Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K152271

### Device Name

Powder Free Nitrile Patient Examination Gloves, Black Color

Indications for Use (Describe)

Powder Free Nitrile Patient Examination Gloves, Black Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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### Section 6 510(k) Summary

# 510(K) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: K152271 =

Premarket Notification [510(k)] Summary

#### 1.0 Submitter:

| Submitter's name : | Suqian Xingye Glove Co,Ltd |
|-------------------------|---------------------------------------------------------------------------------------|
| Submitter's address : | Dongwu Road,Economic Development<br>Zone,Suqian City,Jiangsu<br>Province,223800,China |
| Phone number : | 0086-527-82860533 |
| Fax number : | 0086-527-82860080 |
| Name of contact person: | Jian Zhong Deng |
| Date of preparation : | 2016-01-03 |

### Name of the Device 2.0

| Device Name: | Powder Free Nitrile Patient Examination<br>Gloves, Black Color |
|-------------------------|----------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination<br>Gloves, Black Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |

# 3.0 Predicate device

| Device Name: | Black Nitrile Powder Free Exam Glove |
|----------------|----------------------------------------------|
| Company name: | Shandong Yuanhang Medical Products Co., Ltd. |
| 510(K) Number: | K133307 |

### 4.0 Device Description:

### How the device functions: 4.1 Nitrile films form a barrier to body fluids and bloodborne Pathogens

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#### Scientific concepts that form the basis for the device 4.2

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

### Physical and performance characteristics such as design, materials and 4.3 physical properties:

Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

# 5.0 Device Intended Use (Indication for use):

Powder Free Nitrile Patient Examination Gloves, Black Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

# 6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile Patient Examination Gloves, Black Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Dimension | ASTM standard D 6319-10. | Meets |
| Physical Properties | ASTM standard D 6319-10. | Meets |
| Freedom from pinholes | 21 CFR 800.20 ASTM D 5151-06 (Reapproved 2011) | Meets |
| Powder Residual | ASTM standard D 6319-10 and D6124-06(Reapproved 2011). | Meets<br><2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits<br>ISO 10993-10: Third Edition<br>2010-08-01. | Passes<br>Under the conditions of<br>this study, the test article was<br>a non-irritant |
| | Dermal sensitization in the<br>guinea pig<br>ISO 10993-10: Third Edition<br>2010-08-01. | Passes<br>Under the conditions of<br>this study, the test article was<br>a non-sensitizer |

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# 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Powder Free Nitrile Patient Examination Gloves, Black Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.

The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

## 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data is not needed for the subject device.

### 9.0 Substantial Equivalence Comparison:

| Features &<br>Description | Predicate Device | Subject Device | Result of<br>Comparison |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Company | Shandong Yuanhang<br>Medical Products Co.,<br>Ltd. | Suqian Xingye Glove<br>Co,Ltd | -- |
| 510(K) Number | K133307 | | |
| Product name | Black Nitrile Powder<br>Free Exam Glove | Powder Free Nitrile<br>Patient Examination<br>Gloves, Black Color | same |
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/<br>Large/X large | Small/ Medium/<br>Large/X large | same |
| Indications for<br>use | A disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. | Powder Free Nitrile<br>Patient Examination<br>Gloves, Black Color is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | Substantially<br>equivalent |
| Device<br>Description and<br>Specifications | Meets ASTM<br>D6319-10 | Meets ASTM<br>D6319-10 | Substantially<br>equivalent |
| Dimensions<br>--Length | Meets ASTM<br>D6319-10<br>$≥230$ mm min | 230mm min for all sizes | Substantially<br>equivalent |
| Dimensions<br>-- Width | Meets ASTM<br>D6319-10 | | Substantially<br>equivalent |
| | Small 70-90 mm<br>Medium 85-105mm<br>Large 100-120mm<br>Xlarge 110-130 mm | Small 82-86 mm<br>Medium 94-98mm<br>Large 105-109mm<br>X large 114-120 mm | |
| Dimensions | Meets ASTM | | Substantially |
| --Thickness | D6319-10 | Thickness (mm) min. | equivalent |
| | Finger 0.05mm min. | Finger 0.10-0.12 | |
| | Palm 0.05mm min. | Palm<br>0.06-0.09 | |
| Physical | Meets ASTM D | | Substantially |
| Properties | D6319-10 | | equivalent |
| | Before aging/after aging | Before aging/after aging | |
| | Elongation ≥500% | Elongation :520-620% | |
| | Tensile Strength≥14MPa | Tensile Strength:20-36 MPa | |
| Freedom<br>from | Meets<br>● | Meets ASTM<br>D5151-06 | Substantially<br>equivalent |
| Pinholes | 21 CFR 800.20<br>ASTM D6319-10<br>● | (Reapproved 2011) | |
| | ASTM D 5151-06<br>● | | |
| | (Reapproved 2011) | Holes at | |
| | | Inspection Level I<br>AQL2.5 | |
| Residual | Meets ASTM | Meets ASTM | Substantially |
| Powder | D 6124-06 | D 6124-06 | equivalent |
| | (Reapproved 2011) | (Reapproved 2011) | |
| | below 2mg of residual | Results generated values | |
| | powder | below 2mg of residual | |
| | | powder | |
| Materials used | Nitrile | Nitrile | Substantially |
| to fabricate the | | | equivalent |
| devices<br>Dusting or | PU | PU-120C | Substantially |
| Donning | | | equivalent |
| Powder: | | | |
| Dusting or | Surface Coating Agent | Surface Coating Agent | Substantially |
| Donning<br>Powder: name | | | equivalent |
| Compare | Meets | Meets | Substantially |
| performance | ASTM D5151-06 | ASTM D5151-06 | equivalent |
| data supporting | (Reapproved 2011) | (Reapproved 2011) | |
| substantial<br>equivalence | ASTM D6319-10<br>ASTM D6124-06 | ASTM D6319-10<br>ASTM D6124-06 | |
| | (Reapproved 2011) | (Reapproved 2011) | |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially |
| | | | equivalent |
| Biocompatibility | Under the conditions of<br>this study, the test article | Under the conditions of<br>this study, the test article | Substantially |
| | was a non- irritant or non- | was a non- irritant or non- | equivalent |
| | sensitizer. | sensitizer. | |
| | SKIN IRRITATION | IRRITATION<br>SKIN | |
| | DERMAL and | DERMAL<br>and | |
| | SENSITIZATION | SENSITIZATION | |
| | STUDIES Meets ISO | STUDIES Meets<br>ISO | |
| | 10993-10:2002/Amd.1:2<br>006 | 10993-10: Third Edition<br>2010-08-01. | |
| Labeling for the | -Powder Free | -Powder Free | Substantially |
| legally marketed | -Patient Examination | -Patient Examination | equivalent |
| device to which | Glove | Glove | |
| substantial | -Single Use Only | -Single Use Only | |
| equivalence is<br>claimed. | - Manufactured For:<br>- Lot | - Manufactured For:<br>- Lot | |
| | -Black color | -Black color | |
| | - Non sterile | - Non sterile | |

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#### 10.0 Substantial Equivalence Comparison:

It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Black Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Black Color is as safe, as effective, and performs as well as the predicate device, Black Nitrile Powder Free Exam Glove, Shandong Yuanhang Medical Products Co., Ltd. K133307.

The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.